Department of Health and Human Services October 2024 – Federal Register Recent Federal Regulation Documents

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the proposed new information collection requirements relating to the State Annual Long- Term Care Ombudsman Report (OMB Control Number 0985-0005).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms" and the supplemental document entitled "M13A Bioequivalence for Immediate- Release Solid Oral Dosage Forms: Questions and Answers." The guidance and supplemental questions and answers document were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) assessment of orally administered immediate-release solid oral dosage forms of pharmaceutical drugs, such as tablets, capsules, and granules/powders for oral suspension. The supplemental questions and answers document provides clarity to concepts covered in the guidance and rationales behind to facilitate implementation. The guidance is intended to provide globally harmonized scientific recommendations for conducting BE studies during both the development and postapproval phases of immediate-release solid oral dosage forms. The guidance replaces the draft guidance "M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms" issued on February 1, 2023.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Department of Health and Human Services is correcting a final rule that appeared in the Federal Register on August 21, 2024. The effective date of that final rule was listed in the preamble as the date of publication, August 21, 2024, when it should have had the required 60-day delay to comply with the Congressional Review Act. The effective date should have been October 21, 2024. Additionally, the final rule inadvertently included an incorrect citation in the requirements for family partnership services, and failed to include the compliance date for the requirements for staff benefits (August 1, 2028) in the regulatory text.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Department of Health and Human Services (HHS) (Department) has created the Interagency Pain Research Coordinating Committee (IPRCC) and is seeking nominations for this committee.

The Food and Drug Administration (FDA or we) is responding to the objection that we received from the Environmental Defense Fund, Breast Cancer Prevention Partners, Environmental Protection Network, Environmental Working Group, and Healthy Babies Bright Futures on the final rule that amended the food additive regulations to no longer provide for the use of 25 plasticizers that the petition identified as ortho-phthalates because these food additive uses have been permanently abandoned. After reviewing the objection, FDA has concluded that the objection does not provide a basis for modifying FDA's final rule amending the food additive regulations.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on the draft Vessel Sanitation Program (VSP) Environmental Public Health Standards and VSP Construction Standards. Information about locating these documents can be found in the supporting materials section. VSP established these public health standards to target the control and prevention of environmentally associated illnesses and hazards on cruise ships. VSP inspectors use these standards to conduct operational public health inspections on cruise ships under the program's jurisdiction and to complete cruise ship construction activities at industry request.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the activities associated with the Child and Family Services Reviews information collection (Office of Management and Budget (OMB) #0970-0214, expiration January 31, 2025). There are no changes requested to the collection.

This document sets forth proposed rules that would amend the regulations regarding coverage of certain preventive services under the Public Health Service Act. Specifically, this document proposes rules that would provide that medical management techniques used by non- grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage with respect to such preventive services would not be considered reasonable unless the plan or issuer provides an easily accessible, transparent, and sufficiently expedient exceptions process that would allow an individual to receive coverage without cost sharing for the preventive service that is medically necessary with respect to the individual, as determined by the individual's attending provider, even if such service is not generally covered under the plan or coverage. These proposed rules also contain separate requirements that would apply to coverage of contraceptive items that are preventive services under the Public Health Service Act. Specifically, these proposed rules would require plans and issuers to cover certain recommended over-the-counter contraceptive items without requiring a prescription and without imposing cost-sharing requirements. In addition, the proposed rules would require plans and issuers to cover certain recommended contraceptive items that are drugs and drug-led combination products without imposing cost-sharing requirements, unless a therapeutic equivalent of the drug or drug-led combination product is covered without cost sharing. Finally, this document proposes to require a disclosure pertaining to coverage and cost-sharing requirements for over-the-counter contraceptive items in plans' and issuers' Transparency in Coverage internet-based self-service tools or, if requested by the individual, on paper. These proposed rules would not modify Federal conscience protections related to contraceptive coverage for employers, plans and issuers.

This document corrects technical and typographical errors in the final rule that appeared in the April 15, 2024 issue of the Federal Register entitled, "Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2025; Updating Section 1332 Waiver Public Notice Procedures; Medicaid; Consumer Operated and Oriented Plan (CO-OP) Program; and Basic Health Program." The effective date of the final rule was June 4, 2024.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The National Institute for Occupational Safety and Health (NIOSH) in the Centers for Disease Control and Prevention (CDC), an Operating Division of the Department of Health and Human Services (HHS), requests public comment on the draft Skin Notation Profiles: Allyl alcohol, Formamide, Formic Acid, Phenothiazine, and Picric Acid.

On Thursday, September 26, 2024, the Centers for Medicare & Medicaid Services (CMS) published a 30-day Paperwork Reduction Act of 1995 notice entitled, "Agency Information Collection Activities: Submission for OMB Review; Comment Request." The notice invited public comment on Document Identifier: CMS-10856; Title of Information Collection: Medicaid Managed Care and Supporting Regulations; and Form Number: CMS-10856 (OMB control number 0938-1453). Through the publication of this document we are withdrawing the September 26, 2024, notice in its entirety.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.